Trials Sponsors Conditions Drugs Pricing

Conditions

Diffuse large B-cell lymphoma (DLBCL)High-grade B-cell lymphoma (HGBL)Follicular lymphoma (FL) grade 3B

Outcome Measures

Primary Outcomes (1)

The primary efficacy endpoint is the BORR defined as the proportion of patients with r/r DLBCL, HGBL and FL grade 3B who achieve a complete or partial remission as best response up to 12-months of study treatment according to the 2014 Lugano criteria, as assessed by local investigator review

Secondary Outcomes (17)

2-year progression-free survival (PFS) with a 95% confidence interval. PFS is defined as time from the first dose of study drug until one of the following events occurs, whichever is first: Disease progression, Relapse, Death due to any cause. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment
2-year overall survival (OS) defined as the time from the first dose of study drug to death of any cause. Patients who have not experienced an event at the time of analysis will be censored at the last date known to be alive.
Complete response (CR) rate measured as the number of complete remissions as best response (achieved up to 12 months) divided by the number of patients treated with at least one dose of study drug
Partial response (PR) rate measured as the number of partial remissions as best response (achieved up to 12 months) divided by the number of patients treated with at least one dose of study drug
Time to complete response measured as the time from the start of therapy to documentation of complete remission
+12 more secondary outcomes

Interventions

Epcoritamab (GEN3013)Type not reported

Zynlonta 10 mg powder for concentrate for solution for infusionType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Epcoritamab (GEN3013)
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
Epcoritamab (GEN3013)
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Epcoritamab (GEN3013)
Named ingredient: epcoritamab
View registry record
Epcoritamab (GEN3013)
Named ingredient: epcoritamab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed relapsed/refractory DLBCL based on pathology report (WHO 2022 criteria): a. DLBCL (de novo or transformed), b. High-grade B-cell lymphoma with MYC and BCL2 rearrangements, c. High-grade B-cell lymphoma, not otherwise specified (NOS), d. Follicular lymphoma grade 3B
Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert syndrome, cholestasis due to hepatic hilum adenopathies or liver involvement, or biliary obstruction due to lymphoma, who may have a total bilirubin ≤ 3 times the ULN

Sponsors & Collaborators

Universitaet Muenster
Otherlead

Study Sites (25)

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Mainz, 55131, Germany

Marie-Kristin Tilch+496131170 marie-kristin.tilch@unimedizin-mainz.de

Universitaetsklinikum Jena KöR

Jena, 07747, Germany

Ulf Schnetzke+4936419324550 ulf.schnetzke@med.uni-jena.de

Ortenau Klinikum

Offenburg, 77654, Germany

Cartsen Schwänen+497814722501

Central Study Contacts

Georg Lenz

02518347587 georg.lenz@ukmuenster.de

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

December 17, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-509861-19-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:28:39 UTC

Documents

D1_Protocol_2023-509861-19-00_redacted

You may not qualify if:

Any prior lymphoma-directed therapy, except for first-line chemoimmunotherapy, or any treatment except first-line therapy and CAR-T cell therapy within second-line. Particularly, patients with prior loncastuximab tesirine and any CD3xCD20 bispecific antibody therapy cannot be considered
Known central nervous system (CNS) involvement
Diagnosed or treated for any malignancy other than r/r DLBCL, HGBL or FL grade 3B within the last 3 years, except for adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, non-invasive basal cell or squamous cell skin carcinoma, adequately treated carcinoma in situ without evidence of disease, localized prostate cancer, post-radical prostatectomy with non-rising prostate-specific antigen levels < 0.1 ng/mL, cervical carcinoma of stage 1B or less, non-invasive, superficial bladder cancer or any curable cancer with a CR of > 2 years duration
Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection or any known active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). Patients with serologic markers of HBV immunization due to vaccination (HBsAg negative, Anti-HBc negative, and Anti-HBs positive) will be eligible. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded
CMV-PCR positive at baseline
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or interfere with the feasibility to administer study drugs including active hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
Concurrent treatment with another investigational agent or radiation therapy
Any psychological, cognitive, familial, or social condition that, in the investigator's opinion, compromises the patient's ability to understand the patient information, give informed consent, or comply with the study protocol
Participation in another clinical trial
Known history of hypersensitivity and/or positive serum human anti-drug antibody (ADA) against any component of the study products or of the concomintant medication or an anti-CD19 antibody
History of Stevens-Johnson syndrome or toxic epidermal necrolysis
Clinically significant third space fluid accumulation, such as ascites requiring drainage or pleural effusion that either requires drainage or is associated with shortness of breath
Pregnancy or breastfeeding
Use of any other experimental medication within 30 days or 5 half-lives prior to the start of the study drug (Cycle 1 Day 1)
Close affiliation with the investigational site, such as being a close relative of the investigator or dependent person (e.g., employee or student of the investigational site)
+13 more criteria

Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations